Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE) (DIVERSE)

The purpose of this research study is to enhance inclusion and diversity in clinical trial enrollment by training participants to perform and provide feedback through a community-based protocol review process, called DIVERSE.

Study Overview

• Status: Recruiting
• Conditions: Leukemia; Blood Cancer
• Intervention / Treatment: Other: DIVERSE Review Process

Detailed Description

This research study aims to pilot a protocol review process, called DIVERSE, assessing its feasibility, acceptability, and preliminary efficacy to enhance inclusion and diversity in clinical trial enrollment. Patients and community participants will complete specialized training and provide feedback on clinical trials in development through the DIVERSE process; they will also provide feedback on the process itself. Investigator participants will request review and provide feedback on the DIVERSE process. The study is based on community-based participatory research.

Participation in this research is expected to last about 18 months. It is expected that about 20 patient and community participants and 20 investigators will participate in this research study. The National Cancer Institute and American Society of Clinical Oncology are providing funding for this research study.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Hantel, MD; Phone Number: 617-582-9394; Email: Andrew_Hantel@dfci.harvard.edu
• Study Contact Backup: Name: Oldy S Bejarano, MPH; Phone Number: 857-215-2365; Email: oldy_bejarano@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Andrew Hantel, MD; Phone Number: 617-582-9394; Email: Andrew_Hantel@dfci.harvard.edu
      • Principal Investigator: Andrew Hantel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Study Population

All potentially eligible participants and investigators will be identified through Dana-Farber Cancer/ Harvard Cancer Center hospitals.

Description

CAB Participant Inclusion Criteria:

• Age 18 or older
• English speaking
• Ability to understand and willingness to provide oral consent
• DFCI patient who are in remission from a blood cancer >1 year will be preferred.

CAB Participant Exclusion Criteria:

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers <18 years old)
• Prisoners.
• Unwilling/unable to agree to maintaining the confidentiality of reviews and clinical trial materials, as outlined in Section 9.1
• Note 1: Patients and non-patient community members who are pregnant are eligible. This is a non-interventional study that meets the definition of minimal risk and poses no greater risk to pregnant individuals or fetuses. Pregnancy status will not be assessed.
• Note 2: English fluency is necessary as protocols being reviewed are written in English and cannot be feasibly translated to other languages within the time period necessary to complete timely reviews.

Investigator Participant Inclusion Criteria:

• Age 18 older
• English Speaking
• Site or Principal investigator
• Not a member of the research team

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DIVERSE Community Advisory Board (CAB); Enrolled participants will complete: Confidentiality agreement and demographic questionnaire; Online training and in-person or remote training with study team; Timely DIVERSE review of protocols; Audio recorded meeting (in-person, remote, or via phone call) with study team to present review findings; Semi-structured exit interview and/or focus group with study staff to provide feedback	Other: DIVERSE Review Process; A participant and community-based review system for clinical research protocols that elicits and collects feedback on investigator-initiated protocol reviews.; Other Names: DIVERSE
Other: DIVERSE Investigators; Enrolled investigator participants will complete: Brief Feedback Survey; Request DIVERSE reviews and complete request form; Acceptability of Intervention Measure questionnaire; Semi-structured exit interview and/or focus group with study staff to provide feedback	Other: DIVERSE Review Process; A participant and community-based review system for clinical research protocols that elicits and collects feedback on investigator-initiated protocol reviews.; Other Names: DIVERSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protocol Review Completion Rate	Feasibility is defined as the proportion of eligible protocols that have completed the DIVERSE review process. The target is a review completion of ≥ 60% of eligible protocols.	18 months
Protocol Review Completion Rate Within 35 Days	Feasibility is defined as the proportion of protocols that have completed the DIVERSE review process within 35 days of request. The goal is to have ≥ to 70% of reviews completed within 35 days.	18 months
Proportion of Acceptability of Intervention Measure (AIM) Scores of 10 or Greater	Acceptability is defined as the proportion of AIM scores provided by investigators after protocols have been assessed by the DIVERSE review process with ≥ 60% of AIM scores resulting as ≥10 on a scale of 0 - 20, where scores of 10 or above are considered "acceptable" or greater. The AIM is a 4-item, 5-point Likert scale-based measure.	18 months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI); American Society of Clinical Oncology
• Investigators: Principal Investigator: Andrew Hantel, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Leukemia; Blood Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia; Hematologic Neoplasms
• Other Study ID Numbers: 24-177; K08CA273043 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No